Products Liability and Safety Update August 2011

August 2011

From the editors of Wolters Kluwer Law & Business, this update describes important developments from CCH products liability and safety publications.

If you have any comments or suggestions concerning the information provided or the format used, we'd like to hear from you. Please send your comments to pamela.maloney@wolterskluwer.

Products Liability

Connecticut High Court Rules on Malfunction Theory in Products Cases
The evidence in an action brought by homeowners’ insurer, through its subrogation rights, against the manufacturer of a lawn tractor, which the insurer alleged contained a manufacturing defect in its electrical system that caused a fire resulting in the destruction of the insureds’ home, was insufficient to establish the insurance company’s products liability claim based on the ‘‘malfunction theory,’’ the Connecticut Supreme Court held, reversing a jury verdict. The tractor was extensively damaged in the fire. The court ruled that although the malfunction theory is based on the principle that the fact of an accident can support an inference of a defect, proof of an accident alone is insufficient to establish a manufacturer’s liability. The court specified that the evidence must support a chain of inferences sufficient to link the injury in a case to a product defect and to link the defect to the manufacturer; and held that appropriate limitations must be placed on the application of the malfunction theory when the product has been destroyed in an accident. Also, the court said that when the evidence presented does not remove the case from the realm of speculation, courts must intervene to prevent such cases from reaching a jury. The court concluded that when direct evidence of a specific defect is unavailable, a jury may rely on circumstantial evidence to infer that a product that malfunctioned was defective at the time it left the manufacturer's or seller's control if the plaintiff presents evidence establishing that (1) the incident that caused the plaintiff's harm was of a kind that ordinarily does not occur in the absence of a product defect, and (2) any defect most likely existed at the time the product left the manufacturer's or seller's control and was not the result of other reasonably possible causes not attributable to the manufacturer or seller. In the case at hand, the court determined that although the insurer’s evidence was sufficient to allow the jury to infer that the fire started within the tractor and that the fire most likely started as a result of a failure in the tractor’s electrical system, the evidence did not support an inference that any defect existed in the electrical system when the tractor left the manufacturer’s facilities or at the time it was sold, as the insurer alleged. The insurance company failed to present sufficient evidence to eliminate other reasonably possible secondary causes of the defect and to establish that the fire in the tractor most likely resulted from a defect attributable to the defendant, the state high court held. Further, without direct evidence establishing that any defect in the tractor was attributable to the manufacturer, the insurer could not rely on any other theory to establish its product liability claim. The Connecticut Supreme Court reversed the trial court and remanded the case with direction to grant the manufacturer’s motion for a directed verdict and to render judgment for the lawn tractor manufacturer. (Metro. Property and Cas. Ins. Co. v. Deere and Co. (ConnSCt) CCH Products Liability Reports ¶18,676)

Denial of Class Certification Proper in Aqua Dots Action
Although the federal district court applied the wrong reasoning in deciding that class certification was not available to a group of consumers who purchased Aqua Dots toys, which had been recalled by the manufacturer in cooperation with the Consumer Product Safety Commission [CCH Products Liability Reports ¶18,509], the U.S. Court of Appeals for the Seventh Circuit upheld the decision on alternate grounds. The toys were made with a chemical that, if ingested, could cause nausea, dizziness, drowsiness, agitation, depressed breathing, amnesia, unconsciousness, and death. The district court denied certification on the ground that the proposed class did not meet the superiority requirement because the manufacturer’s refund program provided a better remedy to putative class members, in much less time, and without the expense of substantial judicial resources. According to the appeals court, the district court had concluded that although the recall program was not a form of “adjudication,” as required by the rules governing class certification, it was superior, under application of a “policy approach,” to following the text of the rules. However, the appeals court explained that the lower court’s conclusion that it had a better idea did not justify disregarding the rules. Instead, the appeals court found that certification could be denied on the ground that the representative parties would not fairly and adequately protect the interests of the class. The named representatives sought relief that most buyers already had received under the manufacturer’s recall program. The appellate court further noted that the remedy remained available to other class members. In addition, a representative who proposed that high transaction costs (notice and attorneys’ fees) be incurred at the class members’ expense for the purpose of obtaining a refund that was already available was not adequately protecting the class members’ interests. Finally, the named representatives’ punitive damages claims depended on state law, which created a class management problem because of the variability of state punitive damages laws. (In the Matter of: Aqua Dots Products Liability Litigation (7thCir) CCH Products Liability Reports ¶18,670)

Generic Drug Warning Matter Vacated, Remanded
After having its judgment (Demahy v. Actavis, Inc. [CCH Products Liability Reports ¶18,346]) reversed and the matter remanded for further proceedings by the U.S. Supreme Court in PLIVA, Inc. v. Mensing [CCH Products Liability Reports ¶18,642] in June, the U.S. Court of Appeals for the Fifth Circuit has vacated the U.S. District Court for the Eastern District of Louisiana's order (Demahy v. Wyeth, Inc. [CCH Products Liability Reports ¶18,134]) denying in part the motion to dismiss by the drug manufacturer, Actavis, Inc., and has remanded the matter for the entry of judgment in favor of Actavis, Inc. In PLIVA, the U.S. Supreme Court held that federal law preempted the state law failure-to-warn claims of two patients who developed a severe neurological disorder after taking a generic anti-nausea medication for several years, and who alleged that the manufacturers of the generic drug failed to provide warning labels adequately warning that the disorder could occur in patients after long-term use of the drug. According to the High Court, federal drug regulations applicable to generic drug manufacturers directly conflicted with, and, therefore, preempted, the state-law claims. (Demahy v. Actavis, Inc. (5thCir), No. 08-31204, August 22, 2011)

Failure to Warn Verdict Against Bat Maker Upheld in Montana
In a strict liability action for survivorship and wrongful death damages brought by the parents of a pitcher who was fatally struck in the head by a batted ball that was hit using an aluminum bat, there were genuine issues of material fact regarding the scope of the bat’s warning to submit the matter to the jury, the Montana Supreme Court held, affirming an award of $850,000 on the parents’ failure to warn claim. The parents claimed that the bat was in a defective condition because of the enhanced risks associated with its use—i.e., it increased the velocity speed of a batted ball when the ball left the bat, thereby decreasing infielders’ reaction times, and resulted in a greater number of high energy batted balls in the infield. Under the state supreme court’s jurisprudence, a failure to warn claim could be brought by persons who were not actual purchasers or users of a product. The Montana high court determined that all of the players, including the pitcher, were users or consumers placed at risk by the increased exit speed caused by the manufacturer’s aluminum bat, and the bat maker was subject to liability to all players in the game for the physical harm caused by that increased exit speed. The manufacturer’s argument that providing a warning to bystanders, such as the pitcher in the case, was “unworkable” was rejected because the “workability” or feasibility of providing a warning was a jury question, the court said. The court also held that the manufacturer’s second argument—that the parents could not produce causation evidence establishing that they could have seen, read, and heeded a warning on the bat in a manner to prevent the pitcher’s death—failed because it incorrectly limited the scope of the warning by erroneously assuming that placing a warning directly on the bat was the only method to provide a warning. Other methods of warning existed, including, but not limited to, issuing oral warnings and placing warnings in advertisements, posters, and media releases. These warnings would have communicated to all players the potential risk of harm associated with the bat’s increased exit speed. The court concluded that genuine issues of material fact existed regarding the scope of the warning and that submission of the failure to warn claim to the jury was not error. In addition, the state high court ruled that it was not error to allow the jury, in its deliberations on the parents’ failure to warn claim against the bat maker, to infer that the pitcher would have heeded a warning relating to the bat’s exit speed if one had been given; that the assumption of the risk defense was not applicable in the case because there was no evidence that the pitcher actually knew he would be seriously injured or killed when pitching to a batter who was using one of the manufacturer’s aluminum bats; and that the jury was properly instructed on the parents’ failure to warn claim even though the district court substituted the term “bystander” for “ordinary user of the product.” (Patch v. Hillerich & Bradsby Co. (MontSCt) ¶18,669)

Bluetooth Headset Settlement Vacated Over Fees
An agreement settling a products liability class action relating to Bluetooth headsets—in which the class was provided $100,000 in cy pres awards and zero dollars for economic injury, while setting aside up to $800,000 for class counsel and $12,000 for the class representatives—has been vacated and the matter remanded so that the California federal district court that approved the agreement could “conduct a more searching inquiry into the fairness of the negotiated distribution of funds,” the U.S. Court of Appeals for the Ninth Circuit held. The court also instructed the lower court to “consider the substantive reasonableness of the attorneys’ fee request” given “the degree of success attained” by counsel on behalf of the class. The class action sought money damages on behalf of consumers who had purchased Bluetooth headsets since June 30, 2002, purportedly in reliance on allegedly misleading representations about the safety and usability of the product. The consumers alleged that the headset makers advertised “talk times” of three hours or longer, while in actuality, consumers could not safely use the headsets for more than a few minutes each day without exposing themselves to the risk of noise-induced hearing loss—a risk which the manufacturers failed to disclose in any of their marketing materials. The complaint did not state a claim for personal injury, but asserted economic injury, alleging that the consumers would not have purchased their Bluetooth headsets but for the manufacturers’ false advertising. Consumers sought actual damages in the amount paid for the product, which they claimed to be between $70 and $150 per headset, along with injunctive relief, restitution, punitive damages, attorneys’ fees and costs. Class members (“objectors”) challenged the fairness and reasonableness of the settlement, arguing that the district court abused its discretion in failing to consider whether the gross disproportion between the class award and the negotiated fee award was reasonable. The Ninth Circuit agreed that the disparity between the value of the class recovery and class counsel’s compensation raised “at least an inference of unfairness, and that the current record did not adequately dispel the possibility that class counsel bargained away a benefit to the class in exchange for their own interests.” Upon vacating the approval and fee orders, the court said that it expressed no opinion on the ultimate fairness of what the parties negotiated so as not to substitute its own notions of fairness for those of the district judge. (In re: Bluetooth Headset Products Liability Litigation (9thCir), No. 09-56683, August 19, 2011)

Lack of Admissible Evidence Defeats Drug Preparer Liability
Absent expert testimony, the family of a child who experienced kidney transplant rejection after taking tacrolimus suspension, an immunosuppressant drug, prepared by a pharmaceutical service, could not prove that the drug was subpotent (less than the prescribed amount) and caused the child’s kidney rejection. The family’s expert testimony on causation was properly ruled inadmissible, the U.S. Court of Appeals for the Tenth Circuit held, affirming summary judgment for the pharmaceutical service. The court ruled that without the experts’ causation testimony, the family failed to present a genuine issue of material fact on its products liability tort claim. With respect to the negligence claim, the family could not show that “more likely than not” the tacrolimus suspension was subpotent, that it was the but-for cause of kidney rejection, or that it was the proximate cause of the kidney rejection. Because the family did not establish to a reasonable degree of medical certainty that the pharmaceutical service’s tacrolimus suspension was subpotent, the failure-to-warn claim also failed, as did the family’s claims of breach of express and implied warranties, according to the court. (Huerta v. BioScrip Pharmacy Services, Inc. (10thCir) ¶18,666)

Action Linking Murder-Suicide to Antidepressant to Proceed
In a wrongful death action against the manufacturer of an antidepressant drug brought by the son of a patient who was prescribed the drug, the exclusion of the testimony of the son’s expert witness was affirmed by the U.S. Court of Appeals for the Tenth Circuit. Shortly after the patient’s initial dose was increased, he took his life and that of his wife. However, the court of appeals reversed both an order by the lower court, a federal district court in New Mexico, denying a new scheduling order to allow the son time to name a new expert, as well as a decision by the lower court that, without the expert’s testimony, the son could not put forth any evidence that the drug caused the patient to commit the murder-suicide. The court of appeals found that the son’s request for a new scheduling order occurred when a new judge was assigned to the case, at which time there was no longer any impending trial date or pretrial schedule Because no trial date was set at the time of the request, the appellate court found that there was no reason the district court could not provide ample opportunity for the drug company to test the opinions of the son’s new expert witness, review the witness’s reports, depose the new witness, and adequately defend against that expert at trial. The court also rejected the drug company’s claim of unfairness stemming from extra expense of discovery pertaining to a second expert, finding that extra expense alone was not the type of prejudice that rose to the level of warranting the exclusion of a witness’s testimony under the Tenth Circuit’s precedent. (Rimbert v. Eli Lilly and Co. (10thCir) ¶18,668)

Alabama Statute Barred Claims Against Drug Maker
A patient’s common law negligence claims and products liability claims under the Alabama Extended Manufacturer’s Liability Doctrine (AEMLD), which alleged that a pharmaceutical company’s production and recommendation of a hormone replacement drug caused the patient’s breast cancer, were time-barred under Alabama law, a federal district court held. The court first determined that Alabama, not Minnesota, law applied to the question of whether the patient’s claims were timely. The court then noted that the action had been filed approximately four years after the two-year statute of limitations applicable to AEMLD and negligence claims had run. Although the patient claimed that the time period had been tolled, she did not adequately plead facts showing that the pharmaceutical company knew of, but fraudulently concealed, the dangers of the drug, nor did she plead any evidence of misrepresentation on the part of the drug maker.
However, the court determined that the six-year statute of limitations applicable to common law products liability wantonness claims applied to the patient’s action even though the complaint did not plead wantonness specifically. The court found that wantonness could be implied from allegations that the drug maker acted willfully, intentionally, and/or with reckless disregard for the rights of the patient and the public in failing to warn of the risks associated with the drug. Furthermore, the manufacturer provided a defense to the wantonness claims so it could not argue that it was not on notice of this claim against it. Finally, the court determined that the common law wantonness claim was independent of the patient’s AEMLD wantonness claim, which, like the other AEMLD claims, was barred by the two-year limitations period. Therefore, it survived dismissal. (Scharff v. Wyeth (MDAla) ¶18,675)

$10M Verdict Returned in TASER Wrongful Death Action
In a wrongful death action stemming from the death of a 17-year-old supermarket employee who was shocked in the chest by a police officer using an electrical control device (ECD), manufactured and sold by TASER International, Inc., a federal North Carolina jury found in favor of the employee’s estate and determined that TASER should pay $10 million for its failure to provide an adequate warning or instruction with the ECD. Specifically, the jury found that prior to the shock resulting in the employee’s death, TASER failed to provide an adequate warning or instruction with the ECD that was shipped to the police department (which employed the officer involved in the incident) and was used on the employee. The jury also concluded that the failure to provide adequate warnings was the proximate cause of the employee’s death, and that $10 million in compensatory damages were warranted. In a prior decision which paved the way for the jury verdict, the federal district court ruled that: the estate’s causation expert’s testimony was admissible; sufficient evidence was presented to create a genuine issue of fact for the jury on causation; genuine issues of material fact existed as to whether, under the North Carolina Product Liability Act, the ECD manufacturer failed to provide adequate warning or instruction about the cardiac risks of the ECD’s shots to the chest; the ECD manufacturer failed to present sufficient evidence to establish the defenses of misuse or contributory negligence; and the estate could not recover punitive damages. (Fontenot v. TASER International, Inc. (WDNC), No. 3:10cv125, July 19, 2011; Fontenot v. TASER Int’l, Inc. (WDNC) ¶18,667)

Indiana Products Law Subsumes Tort, Not Contract, Claims
Strict liability and negligence claims brought by a purchaser of a hair care product were consolidated with her Indiana Product Liability Act (IPLA) claim, as were her breach of warranty claims to the extent they were tort-based, a federal district court in Indiana held. However, her claim for breach of implied warranty of fitness for a particular purpose was contract-based and, thus, could proceed because, the court explained, it was not invalidated by the IPLA. The purchaser had alleged that the product burned her scalp, causing extensive and permanent injuries. She sought recovery for her injuries under two separate counts of strict liability, negligence, and breach of express and/or implied warranties. The manufacturer had argued that those claims not pled under the IPLA should be dismissed because IPLA applied to all actions arising out of injuries caused by a product. The court rejected this argument because merger, not dismissal, of all tort-based claims into one claim under IPLA was appropriate in this case. However, the court found that the breach of implied warranty claim, which was based on allegations that the product could not be used safely for the purpose for which it was sold, was a contract-based claim. According to the court, the IPLA did not vitiate the provisions of the Uniform Commercial Code, but allowed contract-based claims arising out of defective products and allowed the purchaser to recover contract damages, including the cost of the product and economic loss, even though the purchaser had not limited her damages under this claim to contract damages. Furthermore, the purchaser’s claim for punitive damages did not automatically make the breach of implied warranty claim tort-based. Even though contract-based warranty claims were recognized by the court as independent claims, the purchaser failed to show that she would be able to discover sufficient evidence to establish vertical privity between herself and the maker of the product. Therefore, the court determined that she could not maintain claims based on breach of express warranty or breach of the implied warranty of fitness for a particular purpose against the manufacturer. Both these warranty claims required the purchaser to show that she was in privity with the person or entity who purchased the product from the manufacturer. The purchaser did not state from whom she bought the product; nor did she allege that she entered into any type of bargain or purchase agreement directly with the manufacturer. Thus, these claims were dismissed. However, because the implied warranty of merchantability did not require a showing of privity, this claim survived insofar as the purchaser sought contract damages. (Atkinson v. P&G Clairol, Inc. (NDInd) ¶18,671)

Patients Must More Clearly Identify Mesh Device Implants
In order to support products liability claims against a manufacturer of mesh devices implanted in patients during abdominal surgical procedures, the patients were not required to identify a specific medical device; however, they had to state whether their claims were based on one common device or on multiple devices that shared a common defect, a California federal district court has ruled. In addition, the patients had to state clearly the jurisdictional location where each procedure had been performed in order to state a defective design and failure to warn claims against the manufacturer. Pleading defective medical device claims was very difficult, the court explained, and discovery was necessary before patients, in fairness, could be expected to provide specific details. To require the patients to identify a device by referencing a specific product line or model number, without the benefit of discovery, could create an insurmountable pleading burden, according to the court. However, the patients did not clearly allege where each had undergone their respective procedures. According to the court, this information was necessary when patients were unable to identify the specific medical device because revealing when, where, and why a product was performed assisted the manufacturer in identifying which of its products was implicated. In addition, the complaint was ambiguous with respect to whether each patient had the same type of mesh device implanted. The complaint implied that the claims were based on the failure of more than one mesh device given the use of the term, “mesh devices,” and referred to the manufacturer’s products “collectively.” Thus, the court directed the patients to amend the complaint to correct these deficiencies. (Coleman v. Boston Scientific Corp. (EDCal) ¶18,664)

SUV Maker Not Liable for Warning, Negligent Design Claims

A driver rendered paraplegic when the 1996 sport utility vehicle (SUV) she was driving rolled over in a crash failed to prove that the manufacturer’s conduct in the design, manufacture, and sale of the SUV was willful and wanton. Consequently, her claim did not meet the exception to the Georgia 10-year repose statute for liability based on negligence, and punitive damages were not warranted, the U.S. Court of Appeals for the Eleventh Circuit ruled, upholding summary judgment for the SUV manufacturer. (Ivy v. Ford Motor Co. (11thCir) ¶18,665)

Product Safety

President Signs Amendments to CPSIA Lead Limits Provisions
On Friday, August 12, President Obama signed into law H.R. 2715 (Public Law 112-28), which makes changes to current consumer product safety standards promulgated by the Consumer Product Safety Improvement Act of 2008 (CPSIA), including applying the lead limit restrictions for children’s products on only those manufactured after the effective date of those limits and excluding, for the most part, used children’s products from those limits. The new law also provides the Consumer Product Safety Commission with greater authority and discretion to implement current law without overburdening “small-batch” manufacturers. Other major changes under the law include:

Creation of exceptions from the lead limits for product parts that require the use of lead if those parts are not likely to be placed in a child’s mouth or ingested or if it is not practical or feasible to remove the excessive lead or make the lead inaccessible;
Establishment of procedures for CPSC to follow in granting exceptions from the lead limits;
Establishment of new lead limits for bicycles and related products at 300 parts per million;
Exclusion of ordinary books and metal bicycle components from the third-party testing requirements;
Exclusion of inaccessible toy component parts from phthalate prohibitions;
Establishment of a process for incorporating updated voluntary standards for durable nursery products;
Granting CPSC authority to modify requirements for tracking labels;
Modification of the process used for handling materially inaccurate reports in the public database; and
Requiring those making database reports to provide the model or serial number of the product or a photograph.

Event Data Recorder Standards Amended by NHTSA
The National Highway Traffic Safety Administration (NHTSA) has amended the requirements for event data recorders (EDRs) as published by the agency on January 14, 2008 [CCH Consumer Product Safety Guide ¶41,974]. The 2008 final rule responded to petitions for reconsideration of the original August 2006 final rule, 49 CFR Part 563, which was issued to establish uniform performance requirements for the accuracy, collection, storage, survivability of onboard motor vehicle crash event data recorders voluntarily installed in passenger cars and other light vehicles. The changes made by the new rule are effective October 4, 2011. (CCH Consumer Product Safety Guide ¶42,062)

Head Restraints Exemption Expanded to Help the Disabled
An existing exemption from certain requirements of the head restraints standard in the context of vehicle modifications to accommodate people with disabilities has been expanded by NHTSA. The rule facilitates the mobility of drivers and passengers with disabilities by updating the exemption to include the corresponding portions of a new, upgraded version of the standard, the right front passenger seating position, and an exemption for persons with limited ability to support their head. This final rule amends one of the “make inoperative exemptions” found in 49 CFR part 595, specifically Subpart C, “Vehicle Modifications To Accommodate People With Disabilities,” relating to the head restraints standard, FMVSS No. 202, “Head restraints.” It sets forth exemptions from the make inoperative provision to permit, under limited circumstances, vehicle modifications that take the vehicles out of compliance with certain federal motor vehicle safety standards when the vehicles are modified for use by persons with disabilities after the first retail sale of the vehicle for purposes other than resale. The regulation was promulgated to facilitate the modification of motor vehicles, allowing accessibility devices, so that persons with disabilities can drive or ride in them. (CCH Consumer Product Safety Guide ¶42,061)

CVS Agrees to Pay $45,000 to Settle Drawstring Violations
The CVS Pharmacy, Inc., of Woonsocket, Rhode Island, has agreed to pay a civil penalty of $45,000 for failing to report immediately to CPSC, as required by federal law, that it had sold children’s jackets with drawstrings that pose strangulation and entanglement hazards to children. The settlement agreement has been provisionally accepted by the Commission in a unanimous decision. In agreeing to the settlement, CVS denied that it knowingly violated the law. (CCH Consumer Product Safety Guide ¶58,260)

Black & Decker Pays $960,000 to Settle Reporting Violations
In settlement of CPSC’s allegations of reporting violations with regard to alleged defects in its hand-held grass trimmer/edgers, Black & Decker has agreed to pay a civil penalty of $960,000.
Between November 2005 and October 2006, Black & Decker imported and distributed about 136,000 newly designed electric, hand-held grass trimmer/edgers known as model GH1000 Grasshog XP (“Grasshog XP”). The Grasshog XPs were sold through retailers nationwide for approximately $70.00. According to CPSC allegations, the Grasshog XPs contained several defects: some of its components could be projected off at high speed in unpredictable directions and could strike the user or bystanders; a component can fall off during use, exposing the user to injury; and a component could overheat, exposing users to risks of burn injuries. (CCH Consumer Product Safety Guide ¶58,245)

Perfect Fitness Agrees to Pay $425,000 Civil Penalty
CPSC has announced a provisional settlement agreement with Perfect Fitness, containing a civil penalty of $425,000. The settlement resolves staff allegations that Perfect Fitness knowingly failed to report immediately to CPSC, as required by federal law, a defect with the Perfect Pullup exercise equipment. Between January 2008 and August 2008, Perfect Fitness manufactured and distributed approximately 10,000 “Perfect Pullup” exercise equipment, which were recalled on February 17, 2011 [CCH Consumer Product Safety Guide ¶58,013]. CPSC staff alleged that although Perfect Fitness had obtained sufficient information to reasonably support the conclusion that the product contained a defect which could create a substantial product hazard, or created an unreasonable risk of serious injury or death, Perfect Fitness failed to inform the Commission immediately of such defect or risk. (CCH Consumer Product Safety Guide ¶58,251)

Children’s Outerwear with Drawstrings Regulated
The Consumer Product Safety Commission has added to the list of products that present a substantial product hazard children’s upperwear outerwear garments in sizes 2T to 12 or the equivalent that have neck or hood drawstrings, and those in sizes 2T to 16 or the equivalent that have waist or bottom drawstrings, and that are subject to the voluntary consensus standard, Standard Safety Specification for Drawstrings on Children’s Upper Outerwear (ASTM F 1816-97), but do not comply with the standard. The new rule, which is effective August 18, 2011, defines “drawstring” as a non-retractable cord, ribbon, or tape of any material to pull together parts of outerwear to provide for closure. In order to help determine whether garments sized under a system other than the numerical system are equivalent to sizes 2T to 16, the rule states that boys’ and girls’ garments size large (L) are equivalent to size 12 while boys’ and girls’ garments size extra-large (XL) are equivalent to size 16. Under the rule, if a garment is labeled for a range of sizes, the garment will be considered subject to ASTM F 1816-97, if any size within the range is subject to ASTM F 1816-97. The rule also provides that the Commission may use any other evidence that would tend to show that an item of children’s upper outerwear is a size that is equivalent to sizes 2T to 16. Finally, the rule does not establish a consumer product safety standard; however, manufacturers of these products are subject to reporting requirements under federal law. (CCH Consumer Product Safety Guide ¶42,057)

Exemptions to Child-Resistant Packaging Issued by CPSC
The Commission has amended, effective July 22, 2011, its regulations governing child-resistant packaging requirements to exempt the powder formulations of two oral prescription drugs, colesevelam hydrochloride and sevelamer carbonate. Colesevelam hydrochloride, currently marketed as Welchol®, is available in a new powder formulation, and is indicated to reduce elevated LDL cholesterol levels and improve glycemic control in adults with type 2 diabetes mellitus. Sevelamer carbonate, currently marketed as Renvela®, is available as a new powder formulation, and is indicated for the control of elevated serum phosphorus in chronic kidney disease patients on dialysis. The rule exempts these prescription drug products on the grounds that child-resistant packaging is not needed to protect young children from serious injury or illness because the products are not acutely toxic, lack adverse human experience associated with acute ingestion, and in their powder form, are not likely to be ingested in large quantities by children under 5 years of age. The Commission noted that a child would have difficulty opening the packet of either of these drugs and mixing the powder with a liquid because of the lack of precision and control required. (CCH Consumer Product Safety Guide ¶42,058)

New Lead Content Limit for Children’s Products Issued
Starting August 14, 2011, manufacturers, importers, retailers and distributors of products designed for children 12 years of age or younger must comply with the new, lower federal limit for total lead content: 100 parts per million (ppm), according to a CPSC notice. Lead is a heavy metal that is toxic for children, and associated with lower levels of learning, impaired hearing, brain damage, and, at high levels, can be fatal. The new 100 ppm lead content limit is the third part of Congress’ directive for the CPSC to phase in the reduced levels for lead content over a three-year period, which started with 600 ppm in February 2009 and then 300 ppm in August 2009, unless the Commission determined it was not technologically feasible for a product or product category. The Commission stated that there was no sufficient evidence to make a determination that the manufacturers could not meet the new lead content limit. Many products currently on the market were also found already compliant with the new limit. The 100 ppm lead content limit does not apply to internal parts of children’s products and certain component parts of children’s electronic devices, like electronic connectors and plugs, including headphone plugs. Lead content levels for children’s products are different from the levels Congress set for lead in paint or surface coatings. The limit for lead in paint or surface coatings is .009% and independent third party testing is required for all paints or surfaces coatings used on children’s products. The CPSC will not enforce independent third party testing requirement for total lead content until December 30, 2011, as a result of a stay of enforcement already in place. However, the stay of enforcement does not apply to children’s metal jewelry, which currently must undergo independent third party testing. (CCH Consumer Product Safety Guide ¶58,230)